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The Effect of Vitamin D on the Consolidation of Extra-articular Fractures - a double-blind randomized controlled trial


- candidate number16211
- NTR NumberNTR4381
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-jan-2014
- Secondary IDs45897 
- Public TitleThe Effect of Vitamin D on the Consolidation of Extra-articular Fractures - a double-blind randomized controlled trial
- Scientific TitleThe Effect of Vitamin D on the Consolidation of Extra-articular Fractures - a double-blind randomized controlled trial
- ACRONYMD-Union
- hypothesisVitamin D supplementation reduces the incidence of delayed union in fracture patients with a vitamin D insufficiency, compared to placebo.
- Healt Condition(s) or Problem(s) studiedVitamin D, Vitamin D deficiency, Vitamin D suppletion , Delayed union, Fracture
- Inclusion criteria- Age between 18 and 50 years - Extra-articular fracture of a long bone (clavicle, humerus, radius, antebrachii, femur, tibia, cruris or Weber A, B or C fracture)
- Exclusion criteria- Refracture; pathologic fracture; complicated fracture; Injury severity Score > 16; pregnancy - Growth hormone deficiency; Immune compromised, sarco´dosis - Use of: Vitamin D, corticosteroids, digoxin, calcium / bisfosfonate, phenobarbital, phenyto´n
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2014
- planned closingdate1-jan-2017
- Target number of participants250
- InterventionsGroup studie medication: 25.000IU Colecalciferol once a month during a period of 4 months. Group placebo: Placebo once a month during a period of 4 months.
- Primary outcomeDelayed union, defined as incomplete consolidation (clinically and radiologically) after 4 months.
- Secondary outcome- Non-union, defined as absent fracture consolidation after 9 months - Complications during fracture healing (infection, mal-Union, refracture, (re)operation). - Perceived pain - Functional recovery - Quality of life - Cost(effectiveness)
- Timepoints1, 4, 8, 12, 16, 26 and 52 weeks after fracture.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. I.B. Schipper
- CONTACT for SCIENTIFIC QUERIESProf. Dr. I.B. Schipper
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsNA
- Brief summaryBackground: A large part of the population has a relative or absolute vitamin D deficiency. Recent, as yet unpublished results show that 70% of the patient population between 18 and 50 years with a fracture has a vitamin D insufficiency (25 (OH) D <75 nmol / L), and 40% has a deficiency (25 (OH) D <50 nmol / L). Vitamin D plays a role in the cellular process of fracture healing. However, the number of available clinical studies on the role of vitamin D on fracture healing is scarce and these studies mainly focus on elderly fracture patients. The clinical effect of vitamin D status and vitamin D supplementation on fracture healing is unknown in the fracture population aged between 18 and 50 years. Study objectives: The influence of the initial vitamin D status and the effect of vitamin D supplementation on the fracture consolidation will be studied. An evidence-based recommendation to vitamin D status and vitamin D supplementation in fracture treatment will be based on the study results. Primarily, the effect of vitamin D supplementation on bone healing, the incidence of delayed fracture healing (delayed union) will be investigated in a vitamin D insufficient fracture population. Secondary the effect of vitamin D supplementation on the occurrence of complications , functional outcome, and health-related quality of life will be investigated. We will also examine the influence of the initial vitamin D status on the fracture healing, and conduct a cost-effectiveness analysis on vitamin D supplementation. Study design: In this double-blind randomized controlled trial, patients are randomized between 25.000IU Colecalciferol once a month for 4 months and placebo once a month for 4 months. Patients will be seen according to a fixed schedule during which fracture healing will be monitored using radiography, and blood samples will be obtained for determination of the vitamin D status. Study population: 250 patients aged between 18 and 50 years, with an extra-articular fracture of a long bone (clavicle, humerus, radius, antebrachii, femur, tibia, cruris or Weber A, B or C fracture).
- Main changes (audit trail)
- RECORD26-jan-2014 - 31-mrt-2014


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